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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010029
Receipt No. R000011744
Scientific Title The influence of yellow sand on Bjerkandera adusta associated chronic cough
Date of disclosure of the study information 2013/02/13
Last modified on 2017/10/06

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Basic information
Public title The influence of yellow sand on Bjerkandera adusta associated chronic cough
Acronym The influence of yellow sand on Bjerkandera adusta associated chronic cough
Scientific Title The influence of yellow sand on Bjerkandera adusta associated chronic cough
Scientific Title:Acronym The influence of yellow sand on Bjerkandera adusta associated chronic cough
Region
Japan

Condition
Condition Chronic cough
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether the arrival of yellow sand influences Bjerkandera adusta associated chronic cough
Basic objectives2 Others
Basic objectives -Others capsaicin cough inhalation test, and the Leicester Cough Questionnaire (LCQ) or cough-related laryngeal sensation questionnaire (C-LSQ) should be performed in chronic cough patients before and after the arrival of yellow sand.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1. Comparison of capsaicin cough threshold, the Leicester Cough Questionnaire (LCQ), cough-related laryngeal sensation questionnaire (C-LSQ) and pulmonary function tesing is performed before and after the arrival of yellow sand.
2. Fungal culture of pharyngeal swabs is made before and after the arrival of yellow sand.
3. Air samples are collected at both 400m and 1.2 m above the ground, and B. adusta is assayed quantitatively before and after the arrival of yellow sand.
Key secondary outcomes Trace of the results of intradermal skin test using an antigenic solution of B. adusta is examined.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Chronic cough patients with stable status aged 20-70 years old
Key exclusion criteria 1) Patients having abnormal shadows on chest X-ray indicative of cough aetiology
2) Patients having wheezing audible
3) Patients having obstructive disorders in pulmonary function testing
4) Patients having severe complications
5) Patients having pulmonary tuberculosis
6) Patients without agreement
7) Patients being pregnant, possible pregnant or breast-feeding a baby
8) Patients judged inappropriate by attending physicians
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiko Ogawa
Organization Ishikawa-ken Saiseikai Kanazawa Hospital.
Division name The Division of Pulmonary Medicine
Zip code
Address Akatsuchi-machi ni 13-6, Kanazawa, Japan 920-0953
TEL 076-266-1060
Email saiseikh@po3.nsknet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruhiko Ogawa
Organization Ishikawa-ken Saiseikai Kanazawa Hospital.
Division name The Division of Pulmonary Medicine,
Zip code
Address Akatsuchi-machi ni 13-6, Kanazawa, Japan 920-0953
TEL 076-266-1060
Homepage URL
Email saiseikh@po3.nsknet.or.jp

Sponsor
Institute Ishikawa-ken Saiseikai Kanazawa Hospital.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Respiratory Medicine, Cellular Transplantation Biology, Kanazawa University Graduate School of Medical Science
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 21 Day
Last follow-up date
2015 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 06 Month 14 Day

Other
Other related information Trace of the results of intradermal skin test using an antigenic solution of B. adusta is examined.

Management information
Registered date
2013 Year 02 Month 13 Day
Last modified on
2017 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011744

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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